Stanford University
Stanford, California, 94304, United States
NCT Number: NCT04017819
Primary Objectives
* Determine the biodistribution of [18F]-C-SNAT4 in 5 healthy volunteers. Secondary Objectives * Determine the dosimetry of [18F]-C-SNAT4 PET in healthy volunteers and patients with lung cancer. * Determine the acute toxicity of [18F]-C-SNAT4 PET in healthy volunteers and patients with lung cancer. * Determine whether uptake in [18F]-C-SNAT4 PET imaging is significantly different in tumor and corresponding contralateral noncancer tissue in patients with lung cancer (tested by Wilcoxon test) before the therapy. * Determine/verify the safety profile of the [18F]-C-SNAT4 radiotracer, as an imaging agent in patients with lung cancer. * Determine the time of maximal [18F]-C-SNAT4 radiotracer uptake post injection.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Stanford, California, 94304, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiotracer- Dose 10 mCi
Positron emission tomography (PET)/Computed tomography (CT) Scan
Time frame: 1 day
Whole-body [18F]-C-SNAT4 PET scans will be performed at 60 min post intravenous injection of the PET tracer in Group 1 of 5 healthy volunteers
Time frame: 1 day
Radiation dosimetry of the [18F]-C-SNAT4 radiotracer will be measured through careful monitoring of each participant's vital signs in Group 1 and group 2. Time-Activity curves will be graphed by measuring activity in various organs using multiple PET/CT scans (1 hour dynamic scan, 1 hour and 2 hours) after tracer injection. Absorbed radiation will be calculated.
Time frame: 7 days
The acute [18F]-C-SNAT4 toxicity will be assessed as related adverse events, including laboratory abnormalities, that occur within 7 days of the infusion of [18F]-C-SNAT4.
Time frame: 1 day
The tumor uptake of [18F]-C-SNAT4 PET will be compared with the corresponding contralateral non-cancer tissue in patients with lung cancer before the therapy in Group 2 and 3. SUVmax measurements will be taken from the pre-treatment scan.
Time frame: 1 day
The time of maximal [18F]-C-SNAT4 radiotracer uptake post-injection will be assessed in Group 2 and 3. Time-Activity Curves (TAC) will be graphed by measuring activity in tumor after tracer injection. The maximal of [18F]-C-SNAT4 radiotracer uptake post-injection in lung cancer patients will be determined from these time activity curves.
Time frame: 7 days
The [18F]-C-SNAT4 PET scan signal from pre-therapy to one week after initiation of therapy in Group 3 will be compared both in treatment responders vs. non-responders. SUVmax will be measured in both the pre-treatment and one-week post-initiation of treatment scans.
Stanford University
Other
Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07042243
Behavior, Behavior, Animal
Gainesville, Florida, United States
View Trial DetailsNCT05708950
Adnexal Diseases, Breast Cancer
Santa Monica, California, United States
View Trial DetailsNCT06051695
Adenoma, Adnexal Diseases
Gilbert, Arizona, United States
View Trial DetailsNCT05645510
Adnexal Diseases, Blood Protein Disorders
Edmonton, Alberta, Canada
View Trial Details